(b)(4).Concomitant medical products: zimmer unicompartmental knee high flex precoat femoral component size e catalog #: 00584201501, lot #: 64392094, zimmer unicompartmental knee articular surface size 4 8mm catalog #: 00584202408 lot #: 64184745.Report source - foreign: (b)(4).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the devices remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event 0001822565-2020-03527, 0001822565-2020-03534.This report was previously submitted erroneously on jun 29, 2020 under manufacturing report number 0001825034-2020-02537.
|
This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|